|
European Medical Device Vigilance
System Guidelines
The European Medical Device
Vigilance System Guidelines version #5 provides clear guidelines for application
with lawful directives (AIMD-Article 8, MDD-Article 10, IVDD-Article 11),
explains the salient purposes of the system itself and describes the respective
responsibilities of manufacturers, IVD manufacturers, medical device users, and
National Competent Authorities (who represent the various units comprised within
the European Economic Area or the EEA). The article focuses on the European
Medical Device Vigilance System responsibilities.
The medical device industry, like most industries, is feeling the attractive
pull of globalization. After all, global connections provide more business and
combine innovative powers, two essential elements that are indispensable in
successful med-device environments. Nevertheless, the beckoning call of global
success isn’t always easy to follow. For many medical device companies (small,
medium and large) new and uncharted regulatory requirements appear as major
roadblocks to global expansion. Companies interested in venturing into Europe,
however, will find that European guidelines (at least those specific to
med-device regulations) are well-defined and often correspond in great measure
with those regulations published by major regulatory bodies in the U.S.
For instance, the European
Medical Device Vigilance System Guidelines version #5 (i.e. MEDDEV-5) provides
clear guidelines for application with lawful directives (AIMD-Article 8, MDD-Article
10, IVDD-Article 11), explains the salient purposes of the system itself and
describes the respective responsibilities of manufacturers, IVD manufacturers,
medical device users, and National Competent Authorities (who represent the
various units comprised within the European Economic Area or the EEA).
Guidelines with a Purpose
Like those guidelines within the
United States, the MEDDEV-5 guidelines have the primary purpose of “the
protection of health and safety of patients, users and others by reducing the
likelihood of reoccurrence of the incident elsewhere.”. The additional purposes
are to conform with many of the principles and textual guidelines promoted by
the Global Harmonization Task Force (GHTF); to introduce the database EUDAMED
and to improve upon past revisions of the MEDDEV guidelines.
Accomplishing MEDDEV Goals
The main purposes of the MEDDEV-5
are accomplished via the European Medical Device Vigilance System which
comprises system responsibilities for the following groups:
Page : 1 |
2 | 3
|
